Who is the manufacturer of ABL90 FLEX ANALYZER?

Radiometer Medical Aps filed the 510(k) submission for ABL90 FLEX ANALYZER (K131988).

What is the FDA product code for ABL90 FLEX ANALYZER?

CHL. It is classified under 21 CFR 862.1120 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ABL90 FLEX ANALYZER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ABL90 FLEX ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ABL90 FLEX ANALYZER

K131988 · Radiometer Medical Aps · CHL · Sep 17, 2013 · Clinical Chemistry

Device Facts

Record ID	K131988
Device Name	ABL90 FLEX ANALYZER
Applicant	Radiometer Medical Aps
Product Code	CHL · Clinical Chemistry
Decision Date	Sep 17, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1120
Device Class	Class 2

Intended Use

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Device Story

The ABL90 FLEX is a portable, automated analyzer for in vitro testing of heparinized whole blood. It measures pH, blood gases, electrolytes, glucose, lactate, and oximetry parameters (total hemoglobin, oxygen saturation, and hemoglobin fractions). The device is used in laboratory, near-patient, or point-of-care settings by trained clinicians. It utilizes potentiometry for blood gases and electrolytes, and amperometry for metabolites (glucose, lactate). The modification introduces software-based suppression of glucose results under specific low pO2 conditions to prevent falsely low readings caused by glucose oxidase interference. The device displays results on a touch screen; clinicians use these outputs to diagnose and manage metabolic and acid-base disorders. The system ensures clinical accuracy by suppressing unreliable glucose data when pO2 is <10 mmHg or when pO2 is 10-25 mmHg with glucose >270 mg/dL.

Clinical Evidence

Bench testing only. Precision study (20-day, CLSI EP5-A2) evaluated glucose performance across three pO2 levels (10, 30, >90 mmHg) with 240 runs per combination. Interference study (n=1512) confirmed bias < 10% for glucose < 270 mg/dL at pO2 10-25 mmHg. Method comparison study against ABL735 (n=510 per analyzer pair) demonstrated R2 ≥ 0.984, confirming equivalence in the specified pO2 range.

Technological Characteristics

Portable, automated analyzer. Sensing: potentiometry (pH, pO2, pCO2, electrolytes) and amperometry (glucose, lactate). Spectrophotometry for hemoglobin. Connectivity: menu-driven touch screen. Power: 230/120 V mains. Software: Microsoft XPE operating system. Modification: software-based result suppression logic.

Indications for Use

Indicated for patients requiring measurement of pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinized whole blood for diagnosis and treatment of acid-base disturbances, electrolyte imbalances, carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia), lactic acidosis, anemia, and carbon monoxide poisoning.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

ABL90 Flex (K122729)

Reference Devices

ABL735

Related Devices

K122729 — ABL90 FLEX · Radiometer Medical Aps · Nov 16, 2012
K123748 — ABL90 FLEX · Radiometer Medical Aps · May 7, 2013
K130144 — ABL90 FLEX · Radiometer Medical Aps · Jul 31, 2013
K120197 — ABL90 FLEX · Radiometer Medical Aps · Mar 19, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "RADIOMETER" in bold, black, sans-serif font. To the right of the word is a circled "R" symbol, which is a registered trademark symbol. The text is horizontally aligned and centered. P 1 7 2013 # 510(k) Summary # k131988 - 1. Administrative #### Device Information ABL90 Flex Device Name: Blood gases (pCO2 and pO2) and blood pH test system Common Name: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Product Code: 21 CFR 862.1120, 862.1600, 862.1345, 862.1170, 864.7425, 864.5620, Device Classification: 862.1145, 862.1665, 862.1150, 864.7455, 862.1660, 862.1450 Class II, II, II, II, II, II, II, II, II, II, II, I (reserved), I (limitation to Classification: · exemption per 21 CFR 862.9 (c)(9)), respectively. Clinical Chemistry (75) and Hematology (81) Classification Panel: Purpose of submission: Introduction of a modification that consists of labeling and software changes that suppress glucose results obtained from samples with pO2 levels below 10mmHg, and to suppress glucose results >270mg/dL obtained from samples with 10mmHg < p02 < 25mmHg. ## Submitter | Company Name: | Radiometer Medical ApS | |---------------|------------------------| | ER Number: | 3002807968 | | Address: | Aakandevej 21 | | | 2700 Broenshoej | | | Denmark | | Phone: | +45 3827 3827 | | Fax: | +45 3827 2727 | ## Application Correspondent | Name: | Gitte Juel Friis | |-----------|---------------------------| | Function: | Regulatory Affairs | | E-mail: | gitte.friis@radiometer.dk | | Phone: | +45 3827 3384 | | Fax: | +45 3827 2727 | ## 2. Description of Device Modification The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoqlobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). ## 3. Intended Use The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX is intended for use by {1}------------------------------------------------ RADIOMETER trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. #### 4. Indications for use pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium (cK*): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa*): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCl¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.) Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoqlobin plus reduced hemoglobin. FO2Hb: oxyhemoqlobin as a fraction of total hemoglobin. FCOHb: carboxyhemoqlobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: methemoqlobin as a fraction of total hemoglobin. FHHb: reduced hemoglobin as a fraction of total hemoglobin. Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically. #### 5. Substantial Equivalence The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate: {2}------------------------------------------------ . 1. 1. 1. 1. . . RADIOMETER R 510(k) Number/Device Manufacturer: K122729 ABL90 Flex, Radiometer Medical ApS · ・ . {3}------------------------------------------------ and the same of the same of the same of the same of the same of the same of the same of the season of the season . | Similarities | Differences | | | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--| | Intended Use The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. | Modified caution to manual: Low pO2 levels can influence the linearity of glucose measurements, and can therefore result in falsely low glucose results. Please note that glucose performance is not specified when the pO2 is less than 10 mmHg (1.33 kPa). The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase. Low pO2 levels can influence the linearity of the glucose sensor. The following table outlines the glucose linearity as a function of the pO2. | | | | | | | | | | Blood Gas Measurement pH, pO2, pCO2 by potentiometry | Modified information to manual: Impact of the pO2 level on Glucose linearity and specifications of the ABL90 FLEX analyzer If the pO2 level in a sample is: Then cGlu linearity specifications only apply to cGlu values between: <10 mmHg (1.33 kPa) Linearity not specified. Glu is not usable. 10 ≤ pO2 < 25 mmHg (1.3 ≤ pO2 < 3.3 kPa) 0.5 - 15 mmol/L (9 - 270 mg/dL) If cGlu >270 mg/dL, the linearity is not specified and the cGlu value not usable. ≥25 mmHg (3.3 kPa) 0.5 - 40 mmol/L (9 - 720 mg/dL) | | | | | | | | | : {4}------------------------------------------------ . : : : # Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression | Predicate: ABL90 Flex (K122729) | | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | Differences | | Electrolyte Measurement cK+, cNa+, cCa2+, cCl- by potentiometry | Software changes: - Suppression of glucose results when pO2 < 10 mmHg - Suppression of glucose results >270mg/dL when pO2 is between 10 - 25mmHg - Message: "Glu not usable" | | Metabolite Measurement cGlu, cLac by amperometry | | | Oximetry Measurement ctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb, FHbF | | | Hemoglobin Measurement Spectrophotometry | | | Identical Performance Characteristics | | | Two-Point liquid calibration | | | Menu driven touch screen | | | Software operating system Microsoft XPE | | | Sample Introduction Aspiration | | | Dimensions (length x width x depth) | | | External Power Source 230/120 V mains | | . : . . . {5}------------------------------------------------ | 6. Design Control Activities | | | | | |-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | # / Hazard | Validations and Verifications activities descriptions | Pre-determined Acceptance criteria | Testing results summary | Meet the acceptance criteria or not? | | 41/Too low Glucose result in the upper reportable range obtained from samples with low pO2 level | Interference study at different pO2 levels and at different glucose levels covering the reportable range of the analyser using fresh heparinized whole blood samples. | Bias: ≤10% for glucose when pO2 is > 10 mmHg when compared to the control | 6 different pO2 levels + pO2 ≥90 mmHg as control 7 different glucose levels 3 analyzers 6 tests of each sample on each analyzer 2 runs Total of 1512 measurements The results are valid under the conditions that - all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg, and - all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL all acceptance criteria are met: Bias < 10% | Passed The acceptance criterion is met under the conditions that all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg, and - all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL | | 48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg | | | | | | 49/Too low Glucose result in the lower and medium reportable range obtained from samples with low pO2 level | Precision study at different pO2 levels and at different glucose levels representing clinical decision points at low, medium and high glucose. | CV%: ≤ 10% | 20 days 3 different pO2 levels 3 different glucose levels 2 tests of each sample each day 2 runs Total of 2160 measurements The results are valid under the conditions that - all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg, and - all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL all acceptance criteria are met: CV% < 10% | Passed The acceptance criterion is met under the conditions that all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg, and all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL | : ・ : : : : : . : · : : : · · ・ : {6}------------------------------------------------ ## 5. Performance Characteristics #### Precision Precision was evaluated according to CLSI guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition", EP05-A2. The study was conducted as a 20 day precision study using serum pool sample of glucose. Three levels of glucose have been analyzed in 2 runs per day with 2 replicates for each level. | Results of Precision Study: | mg/dL | | | | | | |-------------------------------|-----------|-------|-----|------|-----|-----| | cGlu level | pO₂ level | Mean | Sr | ST | CV% | n | | Glu Low $17.8 ± 2.5 mg/dL$ | 10 mmHg | 17.9 | 0.2 | 0.8 | 4.7 | 240 | | | 30 mmHg | 18.0 | 0.1 | 0.8 | 4.3 | 240 | | | >90 mmHg | 18.1 | 0.1 | 0.7 | 4.1 | 240 | | Glu Mid $98.7 ± 9 mg/dL$ | 10 mmHg | 101.7 | 1.1 | 3.8 | 3.7 | 240 | | | 30 mmHg | 101.0 | 0.7 | 3.3 | 3.3 | 240 | | | >90 mmHg | 101.2 | 0.5 | 3.3 | 3.2 | 240 | | Glu High $270 ± 6 mg/dL$ | 10 mmHg | 254.1 | 1.6 | 10.8 | 4.2 | 240 | | | 30 mmHg | 262.3 | 1.1 | 8.8 | 3.4 | 240 | | | >90 mmHg | 271.9 | 1.7 | 7.4 | 2.7 | 240 | #### Method Comparison Method comparison study versus a comparative analyzer (ABL735) has been conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2. This study was an in-house method comparison using untreated donor samples in combination with spiked donor blood where necessary. A total of 52 different donors are used in data mining and approximately 500 samples are measured Linear regression of the pooled data qives a slope of 0.9206, intercept of 0.084 and an Re ≥ 0.95; fulfilling the requirements to slope (0.9 - 1.1), intercept (0) and correlation coefficient (≥ 0.95) {7}------------------------------------------------ ## Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression Image /page/7/Figure/2 description: The image is a scatter plot titled "Average: ABL90 as function of ABL735". The x-axis is labeled "Read out ABL735", and the y-axis is labeled "Read out ABL90". There is a series of data points plotted on the graph, labeled "Series 1", and a dashed line representing y=x. The equation of the trendline is y = 0.9206x + 0.084, with an R-squared value of 0.9895. #### Interference Interference study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition", EP07-A2. This study evaluates the pO2 tension in blood samples as an interfering substance to the glucose measurement. | Results of Interference Study | | | | | | | | |-------------------------------|------------|-------|------|------|------|------|------| | CV% (XTEST- XCONTROL) | pO₂ [mmHg] | 10 | 15 | 20 | 25 | 50 | 80 | | cGLu [mg/dL] | 9 | 3.3% | 3.1% | 3.4% | 1.1% | 3.8% | 0.0% | | | 36 | 1.3% | 1.3% | 0.8% | 0.5% | 0.9% | 0.2% | | | 79 | 2.0% | 1.6% | 0.7% | 0.8% | 0.9% | 0.6% | | | 119 | 2.0% | 1.5% | 1.5% | 0.9% | 1.3% | 0.4% | | | 180 | 4.7% | 2.7% | 2.5% | 0.9% | 0.3% | 0.6% | | | 270 | 7.0% | 6.1% | 3.1% | 2.4% | 2.0% | 1.1% | | | 450 | 13.6% | 9.3% | 7.1% | 3.8% | 5.0% | 0.7% | #### 6. Performance Data The performance data submitted in the original submission (K092686) still apply. #### 7. Conclusion The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate ABL90 Flex (K122729). {8}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 17, 2013 Radiometer Medical ApS C/O Gitte Juel Friis Akandevei 21 2700 Bronshoj DENMARK Re: K131988 Trade/Device Name: ABL90 Flex Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Dated: June 24, 2013 Received: June 28, 2013 Dear Mr. Friis: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {9}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Carol C. Benson -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indication for Use ## 510(k) Number (if known): k131988 ## Device Name: ABL90 Flex Analyzer #### Indication For Use: #### Intended Use: The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-ofcare setting. These tests are only performed under a physician's order. #### Indications for use: pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium (cKT): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. . Calcium (cCalcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use _ (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) # Yung WඳChân -S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k)k131988 {11}------------------------------------------------ Chloride (cCF): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.) Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. FO2Hb: oxyhemoglobin as a fraction of total hemoglobin. FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: methemogiobin as a fraction of total hemoglobin. FHHb: reduced hemoglobin as a fraction of total hemoglobin. Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin, FHbF is seldom used clinically. And/Or × Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) YungW.Chan -S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k)K131988